Status:
COMPLETED
Dose Escalation, Open-Label Clinical Trial to Evaluate Safety, Tolerability and Immunogenicity of a Nipah Virus (NiV) mRNA Vaccine, mRNA-1215, in Healthy Adults
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborating Sponsors:
ModernaTX, Inc.
Conditions:
Nipah Virus Infection
Eligibility:
All Genders
18-60 years
Phase:
PHASE1
Brief Summary
Background: Nipah virus (NiV) is transmitted from animals to humans, from humans to humans, and through contaminated food. Infected people may have a cough and trouble breathing. Some people may deve...
Detailed Description
Design: This Phase I, dose escalation, open label clinical trial was the first study of mRNA-1215 in healthy adults to evaluate the safety, tolerability, and immunogenicity of a Nipah virus (NiV) mRN...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA:
- A volunteer must meet all of the following criteria:
- Healthy adults between the ages of 18-60 years inclusive.
- Based on history and physical examination, in good general health and without history of any of the conditions listed in the exclusion criteria.
- Able and willing to complete the informed consent process.
- Available for clinic visits for 52 weeks after last product administration.
- Able to provide proof of identity to the satisfaction of the study clinician completing the enrollment process.
- Physical examination and laboratory results without clinically significant findings and a Body Mass Index (BMI) of 18 to 35 within the 56 days prior to enrollment.
- Laboratory Criteria within 56 days before enrollment:
- White blood cells (WBC) and differential within institutional normal range or accompanied by the site Principal Investigator (PI) or designee approval.
- Total lymphocyte count \>= 800 cells/microL.
- Platelets = 125,000 - 500,000 cells/microL.
- Hemoglobin within institutional normal range or accompanied by the PI or designee approval.
- Alanine aminotransferase (ALT) \<= 1.25 X institutional upper limit of normal (ULN).
- Aspartate aminotransferase (AST) \<= 1.25 X institutional ULN.
- Alkaline phosphatase (ALP) \<1.1 X institutional ULN.
- Total bilirubin within institutional normal range or accompanied by the PI or designee approval.
- Serum creatinine \<= 1.1 X institutional ULN.
- Negative for HIV infection by an FDA-approved method of detection
- Criteria applicable to women of childbearing potential:
- Negative beta-human chorionic gonadotropin (Beta-HCG) pregnancy test (urine or serum) on the day of enrollment.
- Agrees to use an effective means of birth control from at least 21 days prior to enrollment through the end of the study.
- EXCLUSION CRITERIA:
- A volunteer will be excluded if one or more of the following conditions apply:
- Breast-feeding or planning to become pregnant during the study.
- More than 10 days of systemic immunosuppressive medications or cytotoxic medications within the 4 weeks prior to enrollment or any within the 14 days prior to enrollment.
- Blood products within 16 weeks prior to enrollment.
- Any vaccine, including COVID-19 vaccines, received within 4 weeks prior to enrollment.
- Investigational research agents within 4 weeks prior to enrollment or planning to receive investigational products while on the study
- Current allergy treatment with allergen immunotherapy with antigen injections, unless on maintenance schedule.
- Current anti-TB prophylaxis or therapy.
- Known immediate hypersensitivity to any component of the study product, including polyethylene glycol (PEG).
- Confirmed past NiV infection, prior residence in (\>6 months), or planned travel for any length of time during the study to countries where NiV infection is endemic, eg. Bangladesh, India, Philippines.
- Volunteer has a history of any of the following clinically significant conditions:
- Serious reactions to vaccines that preclude receipt of the study vaccination, including allergic reaction (anaphylaxis, urticaria or allergic reaction requiring medical intervention) to SARS-CoV-2 mRNA vaccines, as determined by the investigator
- History of myocarditis and/or pericarditis
- Hereditary angioedema, acquired angioedema, or idiopathic forms of angioedema
- Asthma that is not well controlled
- Diabetes mellitus (type I or II), with the exception of gestational diabetes
- Thyroid disease that is not well controlled
- Idiopathic urticaria within the past year
- Autoimmune disease or immunodeficiency
- Hypertension that is not well controlled
- Bleeding disorder diagnosed by a doctor (e.g. factor deficiency, coagulopathy, or platelet disorder requiring special precautions) or significant bruising or bleeding difficulties with IM injections or blood draws
- Malignancy that is active or history of malignancy that is likely to recur during the period of the study
- Seizure disorder other than 1) febrile seizures, 2) seizures secondary to alcohol withdrawal more than 3 years ago, or 3) seizures that have not required treatment within the last 3 years.
- Asplenia, functional asplenia or any condition resulting in the absence or removal of the spleen
- Guillain-Barre Syndrome
- Any medical, psychiatric, social condition, occupational reason or other responsibility that, in the judgment of the investigator, is a contraindication to protocol participation or impairs a subject s ability to give informed consent, including but not limited to clinically significant forms of: infectious diseases, drug or alcohol abuse, autoimmune diseases, psychiatric disorders, or heart disease.
Exclusion
Key Trial Info
Start Date :
July 11 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 17 2024
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT05398796
Start Date
July 11 2022
End Date
September 17 2024
Last Update
October 23 2025
Active Locations (1)
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1
National Institutes of Health Clinical Center
Bethesda, Maryland, United States, 20892